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NCT ID: NCT04891614 Completed - Clinical trials for Post-Traumatic Stress Disorder (PTSD)

The PRISM Pilot Trial for Post-Traumatic Stress Disorder

Start date: November 29, 2020
Phase: N/A
Study type: Interventional

A Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD)

NCT ID: NCT04889950 Completed - Dry Eye Clinical Trials

Clinical Study to Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction

Start date: October 26, 2021
Phase: N/A
Study type: Interventional

A Randomized, Masked (Evaluator), Controlled, Prospective Pilot Study of the Effectiveness and Safety of the Tixel®, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction. Up to 30 patients (60 eyes) to be randomized in up to 2 clinical sites in Israel and/or Europe. study subject will receive three (3) treatments with Tixel in a monthly interval, and a single treatment for the control group. Follow-up will occur 1 month and 3 months following the last treatment.

NCT ID: NCT04886830 Completed - Clinical trials for All Appendectomies Performed During the Designated Period in Single Medical Center

Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.

Start date: January 1, 2010
Phase:
Study type: Observational

comparing the rate and severity of postoperative complication after LA in regards of different appendiceal stump closure techniques. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.

NCT ID: NCT04877873 Completed - Clinical trials for Osteoarthritis, Knee

Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery

Start date: October 19, 2020
Phase:
Study type: Observational

Knee Osteoarthritis (OA) is one of the most common conditions causing disability and limitation in the elderly population, with 13% of women and 10% of men over the age of 60 suffering from symptomatic knee osteoarthritis. Pain and other symptoms of OA significantly affect the quality of life, manifesting itself in pain, decreased range of motion, functional limitation and change in gait patterns. Total Knee Replacement Surgery (TKR) is the most common solution for patients with advanced cartilage erosion and is considered a successful surgery with high satisfaction rates (about 80%). The surgery becomes necessary when pain limits the daily functioning and impairs the quality of life and after the failure of conservative treatment. Still, patients undergoing TKR suffer in the first period after surgery from pain, decreased balance and proprioceptive impairment. Despite the improvement in pain and function, the rates of falls after surgery do not change drastically and remain high. About a third of older adults fall each year, leading to fractures, functional decline and in some cases death. Walking is a complex task, and with advancing age walking becomes less automatic and requires additional attention. Among adults, it is known that an increased risk of falls is associated with reduced ability to perform complex walking tasks, such as walking while talking or crossing obstacles. After TKR, most falls occur while walking due to slipping / tripping. In addition, proprioceptive impairment, pain and poor balance are associated with an increased risk of falling after TKR. The mechanism underlying these effects may be increased allocation of cognitive resources to walking. Thus, this study will examine the ability of people before and after TKR to perform complex walking tasks, in order to examine the change in attention allocation to walking following surgery. It is hypothesized that after surgery, the ability to walk while performing an additional task will be lower than prior to surgery.

NCT ID: NCT04864834 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration

Mylight
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

NCT ID: NCT04861519 Completed - Stable Angina Clinical Trials

Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device

AutocathFFR
Start date: May 9, 2021
Phase:
Study type: Observational

Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined intuitively and based on the physician eyeball. By using real-world historical data of invasive FFR, the analysis of the obtained data can ensure that the study results are expected to include invasive FFR results that are in the grey zone, when invasive FFR is used in real life and represent the real expected use of the product. Furthermore, the analysis of the data obtained in the studies with these similar devices measuring FFR obtained from angiograms was actually performed in a retrospective manner. That is, although the angiographic images and pressure wire recordings were obtained in real-time, due to the need to mark the vessel in real-time and obtain specific projections during the procedure without which the FFR cannot be calculated, the primary endpoint (sensitivity and specificity) and accuracy were determined in all studies by a post-hoc review by a similar independent QCA core laboratory. The invasive FFR data, as well as the software generated FFR data were reviewed post-hoc by a core laboratory or even at the company.

NCT ID: NCT04854473 Completed - Clinical trials for Open/ Laparoscopic/ Robotic Resection of the Colon

Collection of Electrophysiological Data During Colon Resection

Start date: June 4, 2020
Phase: N/A
Study type: Interventional

The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.

NCT ID: NCT04851561 Completed - Covid19 Clinical Trials

Post-coronavirus Disease-2019 Fatigue

Start date: March 2, 2021
Phase:
Study type: Observational

Background: COVID-19 is consistently spreading throughout the world, and the number of recovered patients is steadily increasing. Accordingly, a significant number of individuals will develop persisting post-COVID symptoms, while many of them will report on lasting fatigue. The main objective of the current study is to assess risk factors for the development of post-COVID-19 fatigue symptoms. As a secondary aim, the current study is intended to identify pathophysiology and explanatory mechanisms for the post-COVID-19 fatigue. Study design and population: a nested case-control study will be conducted at Rabin Medical Center (RMC), Beilinson Hospital. RMC runs a post-COVID-19 clinic for adult (age ≥18 years) recovered individuals (diagnosed using a polymerase chain reaction test from a nasopharyngeal sample), who are invited for a comprehensive medical evaluation. During a visit, all individuals undergo pulmonary function testing and an evaluation by an infectious diseases physician, a pulmonologist, and a social worker. The cohort of recovered COVID-19 individuals evaluated at RMC will serve as the population from which the current study participants will be consecutively sampled. The cases would be defined as such if report on lasting fatigue symptoms which appeared following COVID-19, while at least two months have elapsed since COVID-19 diagnosis and the lasting fatigue symptoms are present for at least six weeks. The controls would be defined as those that did not report on fatigue symptoms at any time point since one month following their diagnosis with COVID-19. Evaluation protocol of cases and controls: All participating individuals (cases and controls) will be assessed following the study protocol. The assessment will be conducted as follows: First assessment meeting (approximately one hour long) in which the participant will undergo physical examination and blood tests, fill the study questionnaires [demographic, clinical and post-COVID fatigue questionnaire; sleep assessment questionnaires (Epworth sleepiness score [ESS], Pittsburg sleep quality index [PSQI], Insomnia severity index (ISI)]) and depression severity questionnaire (the patient health questionnaire-9 [PHQ-9]), and conduct cognitive fatigue task. Second assessment meeting: (approximately one hour long) in which the participants will undergo a cardiopulmonary stress test (CPET). Data collection: The main dependent variable will be the presence of continuing fatigue symptoms. The independent variables included demographic and clinical characteristics. The demographic variables will include: age at diagnosis, sex, marital status and number of children, occupational status (employed, unemployed, or retired), education (number of years at school and higher education), and occupation. The clinical variables will include: smoking status, alcohol and cannabis consumption, basic physical function (independent, limited in certain activities, dependent in activities of daily living, or bedridden), background illnesses, and pharmacotherapy. The acute COVID-19 history will be also collected: disease severity according to the WHO criteria, symptoms (sore throat, nasal congestion, headache anosmia/disguesia, cough, shortness of breath, chest pain, gastrointestinal symptoms, and myalgia), need for hospitalization, hospital complications (veno-thromboembolism, super-imposed bacterial infections), for individuals who were not hospitalized - the site of isolation (home, hotel or another isolation facility) will be collected, time from onset to symptoms resolution, pharmacotherapy directed at COVID-19, and information of other household or family members who were also diagnosed. Statistical methods: Demographic and clinical variables of the patients with fatigue symptoms (cases) and control group (free from fatigue symptoms) will be compared using bivariate and multivariable conditional logistic regression models. Independent variables will be selected to be included in the multivariable model based on the bivariate analysis. Odds ratios and 95% confidence intervals will be obtained from the conditional logistic regression models. P<0.05 will be considered statistically significant. Sample size calculation: Disease severity may serve as a potential risk factor for the development of lasting fatigue symptoms. A preliminary analysis revealed that in our cohort of recovered COVID-19 patients, 20% were hospitalized due to their disease's severity. We will therefore assume that the proportions of individuals required hospitalization during the acute phase were 30% and 10% of the cases and controls, respectively. It is also likely that approximately two thirds of our sample would report on persisting fatigue. Under these assumptions, a sample size of 153 individuals (102 in the cases group and 51 in the control group) will yield a statistical power of 80% at a significance level of 5% for detecting a difference of 0.2 between two proportions.

NCT ID: NCT04843748 Completed - Cataract Clinical Trials

Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL

Start date: August 18, 2018
Phase: N/A
Study type: Interventional

Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.

NCT ID: NCT04842708 Completed - Covid19 Clinical Trials

Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis

COVID-19
Start date: December 24, 2020
Phase: N/A
Study type: Interventional

The objective of this study will be to evaluate the effect of vaccination on breath VOC content. By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.